Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06134687
Status
Recruiting
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Conditions

  • Gastrointestinal Neoplasm

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Submucosal Dissection — PROCEDURE
    Removal of study eligible lesions per endoscopic submucosal dissection
  • Novel Rigidizing Overtube — DEVICE
    Utilization of the Novel Rigidizing Overtube (Pathfinder) to aid in performing colonic endoscopic submucosal dissection

Study Details

The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

Key Dates

Start date
Jun 4, 2024
Status verified
Aug 2025
Primary completion
Dec 4, 2026
Completion
May 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Treatment arm
    Will have endoscopic submucosal dissection performed with the use of the Pathfinder Endoscope Overtube.
  • Active Comparator: Control arm
    Will have endoscopic submucosal dissection performed through conventional means (i.e. without the Pathfinder Endoscope Overtube).

Primary Outcome Measure

Total Procedure Time [ Time Frame: Day 1 (procedure day) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Mohamed O. Othman, MD
[email protected]
713-798-0950
Baylor St. Lukes Medical Center (BSLMC)HoustonTexas77030
Mohamed O. Othman, MD
[email protected]
713-798-0950
Michael Mercado
[email protected]
7137983606

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By research site
Baylor College of Medicine· Houston, TXBaylor St. Lukes Medical Center (BSLMC)· Houston, TX

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